MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery (Pivotal)
This study has been completed.
Sponsor:
Dune Medical Devices
Information provided by:
Dune Medical Devices
ClinicalTrials.gov Identifier:
NCT00749931
First received: September 7, 2008
Last updated: June 25, 2010
Last verified: June 2010
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Purpose
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Device: MarginProbe Procedure: Lumpectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery |
Resource links provided by NLM:
Further study details as provided by Dune Medical Devices:
Primary Outcome Measures:
- The primary effectiveness endpoint is a measure of intraoperative success in addressing positive margins as detected by permanent pathology)by additional oriented tissue re-excision from the surgical cavity. [ Time Frame: two weeks after surgery ] [ Designated as safety issue: No ]
| Enrollment: | 664 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SOC
Standard of Care arm - standard of care lumpectomy procedure
|
Procedure: Lumpectomy
Standard of care lumpectomy procedure
|
|
Experimental: Device + SOC
Use of the device in addition to the standard of care lumpectomy procedure.
|
Device: MarginProbe
Device use to assess margin status of the excised specimen surface.
Procedure: Lumpectomy
Standard of care lumpectomy procedure
|
Detailed Description:
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women histologically diagnosed with carcinoma of the breast
- Women with non-palpable malignant lesions, requiring image guided localization.
- Undergoing lumpectomy (partial mastectomy) procedure.
- Age 18 years or more
- Signed ICF
Exclusion Criteria:
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Bilateral disease (diagnosed cancer in both breasts)
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same breast
- Implants in the operated breast
- Pregnancy
- Lactation
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749931
Locations
| United States, California | |
| Pacific Breast Care | |
| Costa Mesa, California, United States, 92627 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Cedars Sinai Hospital | |
| Los Angeles, California, United States, 90048 | |
| HOAG Memorial Hospital | |
| Newport Beach, California, United States, 92658-6100 | |
| St. Joseph Hospital | |
| Orange, California, United States, 92868 | |
| UCIrvine Medical Center | |
| Orange, California, United States, 92868 | |
| United States, District of Columbia | |
| Georgetown University Hospital | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Maryland | |
| Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| Mercy Hospital Services | |
| Baltimore, Maryland, United States, 21202 | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| St. Luke's Roosevelt | |
| New York, New York, United States, 10019 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| NYU Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| Weill Medical College of Cornell University | |
| New-York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| Breast Care Center | |
| Allentown, Pennsylvania, United States, 18104 | |
| Bryn Mawr Hospital | |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| United States, Virginia | |
| Virginia Hospital Center | |
| Arlington, Virginia, United States, 22205 | |
| Israel | |
| Haddasah Medical Organization | |
| Jerusalem, Israel | |
| Shaare Zedek | |
| Jerusalem, Israel | |
| Assaf Harofeh Medical Center | |
| Zrifin, Israel, 70300 | |
Sponsors and Collaborators
Dune Medical Devices
Investigators
| Principal Investigator: | Tanir M. Allweis, MD | Hadassah Medical Organization, Israel |
| Principal Investigator: | Moshe Carmon, MD | Shaare Zedek Medical Center, Israel |
| Principal Investigator: | Tami Karni, MD | Assaf Harefeh Medical Center, Israel |
| Principal Investigator: | Alison Estabrook, MD | St. Luke's Roosevelt, NY, USA |
| Principal Investigator: | Freya Schnabel, MD | NYU Clinical Cancer Center, NY, USA |
| Principal Investigator: | Rache M. Simmons, MD | Weill Medical College of Cornell University, NY, USA |
| Principal Investigator: | Sheldon M. Feldman, MD | Columbia University Medical Center, NY, USA |
| Principal Investigator: | Mark A. Gittelman, MD | Breast Care Specialist, Allentown, Pennsylvania, USA |
| Principal Investigator: | Neil Friedman, MD | Mercy Health Srvices, Baltimore, USA |
| Principal Investigator: | Kristen L. Fernandez, MD | Franklin Square Hospital Center, Baltimore, USA |
| Principal Investigator: | Shawna C. Willey, MD | Georgetown University Hospital, Washington, USA |
| Principal Investigator: | Lorraine Tafra, MD | Anne Arundel Medical Center, Annapolis, USA |
| Principal Investigator: | Karen Lane, MD | UCIrvine Medical Center, California, USA |
| Principal Investigator: | Jay Harness, MD | St. Joseph Hospital, California, USA |
| Principal Investigator: | Alice Police, MD | Pacific Breast Care, California, USA |
| Principal Investigator: | Dennis R. Holmes, MD | University of South California, California, USA |
| Principal Investigator: | Scott Karlan, MD | Cedars Sinai Hospital, California, USA |
| Principal Investigator: | Stephanie Akbari, MD | Virginia Hospital Center |
| Principal Investigator: | Thomas Frazier, MD | Bryn Mawr Hospital |
| Principal Investigator: | Lisa E. Guerra, MD | HOAG Memorial Hospital |
| Principal Investigator: | Susan K. Boolbol, MD | Beth Israel Medical Center, NY, USA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Galit Itzhaki, Study Manager, Dune Medical Devices Inc. |
| ClinicalTrials.gov Identifier: | NCT00749931 History of Changes |
| Other Study ID Numbers: | CP-03-001 |
| Study First Received: | September 7, 2008 |
| Last Updated: | June 25, 2010 |
| Health Authority: | United States: Food and Drug Administration Israel: Ministry of Health |
Keywords provided by Dune Medical Devices:
|
IDC, DCIS, ILC |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013